US6716244B2 - Sewing cuff assembly for heart valves - Google Patents
Sewing cuff assembly for heart valves Download PDFInfo
- Publication number
- US6716244B2 US6716244B2 US09/745,233 US74523300A US6716244B2 US 6716244 B2 US6716244 B2 US 6716244B2 US 74523300 A US74523300 A US 74523300A US 6716244 B2 US6716244 B2 US 6716244B2
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- US
- United States
- Prior art keywords
- lock ring
- ring
- heart valve
- valve
- valve body
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
Definitions
- the present invention relates to the field of prosthetic heart valves and more particularly to a valve having a sewing cuff assembly that may be easily and securely coupled to the valve for implantation in an annulus of a human heart.
- the invention relates to a method for attaching a sewing cuff to a prosthetic heart valve.
- Prosthetic heart valves are used to replace diseased heart valves in humans.
- Prosthetic heart valves include mechanical heart valves, bioprosthetic valves using biological tissue, and polymer valves.
- the term “mechanical valve” as used herein refers to bi-leaflet heart valves comprising a valve orifice fabricated at least in part of a rigid, biologically compatible material such as pyrolytic carbon, and comprising essentially no biological components.
- biological valve refers to a bi-leaflet or tri-leaflet heart valve comprising at least some biological components such as tissue or tissue components.
- tissue valves are obtained from a donor animal (typically bovine or porcine), and the valve may comprise either biological materials alone or biological materials with man-made supports or stents.
- polymeric valve refers to a tri-leaflet or bi-leaflet heart valve comprising at least some elastomeric polymer components, including at least elastomeric polymer valve leaflets.
- Conventional prosthetic heart valves typically include an annular valve body comprising an orifice for blood flow through the valve.
- the valve body can be made of materials such as biocompatible pyrolitic carbon (mechanical valves), porcine or bovine pericardium tissue (bioprosthetic valves), or silicone or polyurethane (polymer valves).
- Leaflets are coupled to the annular body for movement between an open position and a closed position to allow or prevent blood flow through the orifice.
- Heart valves may include one, two or three leaflets.
- the leaflets can he made of pyrolytic carbon, treated tissue, or polymers.
- the valve is typically attached to a human heart with sutures via a sewing cuff, or some other mechanical attachment means (e.g., staples).
- Sewing cuffs generally comprise a toroidal member that is attached to the periphery of the annular valve body to form a site for anchoring sutures to the annulus of the heart during implantation of the heart valve.
- Sewing cuffs are typically covered with a cloth material, such as polyester, and may also comprise a filler material such as Teflon felt or Dacron cloth.
- the sewing cuff may be coupled to a peripheral groove on the lower end of the valve body by circumferential cinch-like sutures, or may be mechanically captured adjacent to a stiffening ring, as in U.S. Pat. Nos. 5,397,346 and 5,397,348, hereby incorporated by reference herein.
- Another problem associated with prosthetic heart valves is the size and configuration of the suture cuff used to attach the heart valve in the body. It is desirable to maximize the flow area (i.e. the orifice) of the valve. Accordingly, the radial thickness added by the sewing ring is desirably kept to a minimum.
- some replacement heart valve designs have large or bulky sewing cuffs, thereby reducing the area available for blood flow. These designs may include additional material located on the outer diameter of the base of the replacement valve. The added bulk of the sewing cuff also makes the valve less flexible, thus making conformation to natural anatomy more difficult.
- a heart valve and sewing cuff which can be assembled together with a minimum of handling, and a method for rapidly and securely affixing a sewing cuff to a heart valve.
- the assembled valve preferably minimizes the radial thickness of the sewing cuff assembly and maximizes the blood flow orifice area.
- the present invention generally provides a sewing cuff assembly and a heart valve to which the sewing cuff assembly is coupled.
- the invention further provides a method for attaching a sewing cuff assembly to a heart valve and attaching the assembled heart valve and sewing cuff assembly in a human heart.
- embodiments of the invention provide a heart valve comprising a valve body having an outer circumferential rim and a suture cuff assembly comprising at least one lock ring and a material disposed at least partially around and secured to the lock ring.
- the suture ring may include a filler material disposed inside at least a portion of the material disposed around the lock ring.
- a sewing ring for a heart valve comprising at least a pair of lock rings and an attachment material disposed at least partially around the pair of lock rings.
- a filler material may be disposed at least partially between the attachment material and the lock rings.
- FIG. 1 is a perspective view of a heart valve having a cuff assembly attached thereto.
- FIG. 2 is a partial cross sectional view of a valve body having one embodiment of a suture cuff assembly attached thereto.
- FIG. 3 is a cross sectional view of another embodiment of a lock ring and suture cuff assembly.
- FIG. 4 a perspective view of a heart valve sewn into an annulus of a heart.
- FIG. 1 is a perspective view of a tri-leaflet prosthetic heart valve 10 having an annular valve body 12 and three flexible leaflets 14 made of a bio-compatible polymer such as silicone or polyurethane.
- a stent 16 made of metal or plastic, is disposed in or otherwise coupled to the valve body 12 for reinforcement.
- a sewing cuff assembly 18 is coupled to the base of the valve body 12 . The sewing cuff assembly allows a surgeon to suture the prosthetic heart valve 10 to the natural heart.
- FIG. 2 is a partial cross sectional view of a heart valve 10 illustrating one embodiment of a sewing cuff assembly 18 .
- the valve body 12 includes a base portion 15 having a periphery 20 defining a radius RP.
- the radius RP is defined by the outer radius of stiffening ring 26 .
- the periphery 20 of valve body 12 comprises a groove 22 defining a radius RG for receiving a pair of lock rings 24 , 25 for securing the sewing cuff assembly 18 to the valve body 12 .
- Lock rings 24 , 25 preferably have the same radius RL.
- the radius RL of the lock rings is less than the radius RP of the valve periphery 20 . This ensures that the rings 24 , 25 are securely held in groove 22 .
- the radius RL of the lock rings 24 , 25 is also greater than the radius RG of groove 22 . This further ensures that, when located within groove 22 , rings 24 , 25 do not place stress on the periphery 20 of valve body 12 .
- the groove 22 may also comprise a stiffening ring 26 .
- the stiffening ring 26 is disposed in the groove 22 and coupled to or otherwise secured to the heart valve by molding, press fitting the component into place, or other fabrication techniques known in the art., e.g. adhesives.
- the stiffening ring 26 can be made of biocompatable material such as cobalt chromium or titanium and provides a rigid channel 28 in which the lock rings 24 , 25 can be received to secure the sewing cuff assembly 18 to the valve body 12 .
- the stiffening ring can be a continuous ring or can be discontinuous.
- the stiffening ring can form a lower portion of a stent in the valve body. In this configuration, the stent may be formed with a groove in its lower portion defining a channel to receive the lock rings 24 , 25 .
- U.S. Pat. Nos. 5,397,346 and 5,397,348 disclose exemplary methods of incorporating stiffening rings into a prosthetic heart valve.
- the embodiment of the suture cuff assembly 18 shown in FIG. 2 includes two lock rings 24 , 25 having an outer covering 30 coupled thereto.
- the outer covering can be polyester, Teflon felt or Dacron.
- the lock rings 24 , 25 are preferably continuous rings made from a biocompatible material such as titanium.
- the lock rings 24 , 25 can have a circular, square (as shown in FIG. 2 ), rectangular or other geometric cross section.
- the outer covering 30 is attached to the lock rings with stitches 32 , 34 .
- each end of the outer covering 30 is wrapped around a lock ring 24 , 25 and then stitched, thereby enclosing the lock ring in the suture material.
- Other methods of coupling the suture material to the lock rings, such as stapling, will be apparent to persons of skill in the art.
- a filler material 36 can optionally be placed within an interior of the outer covering 30 defined when the suture material is stitched around the lock rings 24 , 25 .
- Filler material can include Teflon felt or Dacron, for example.
- the filler material 36 provides rigidity and reinforcement to the outer covering 30 on implantation into a heart.
- the sewing cuff assembly 18 including both the outer covering 30 and the filler material 36 , if used, also help prevent perivalvular leakage around valve 10 when the valve is closed.
- a suture cuff assembly can be assembled and coupled to a heart valve as follows.
- the pair of lock rings 24 , 25 are positioned inside opposing ends of the cloth tube, such as a polyester tube, and sutured, stapled or otherwise secured in place.
- An optional filler material 36 can be positioned adjacent the outer covering 30 and enclosed between the two lock rings 24 , 25 .
- a stiffening ring 26 such as a U-shaped ring as illustrated in FIG. 2, is coupled to channel 28 and groove 22 in heart valve periphery 20 .
- the lock-rings 24 , 25 are then snapped fit around the stiffening ring 26 into channel 28 (and groove 22 ) in valve body 12 .
- the lock rings 24 , 25 are made of a material, such as titanium, which enables the lock rings 24 , 25 to be positioned in the groove 22 in much the same way as a clincher bicycle tire is fitted onto a bicycle rim.
- Channel 28 , stiffening ring 26 , and groove 22 prevent both vertical and lateral displacement of the suture cuff assembly 18 while enabling rotation of the lock rings 24 , 25 (and thus sewing cuff assembly 18 ) relative to valve body 12 .
- the assembled heart valve can then be sutured into the annulus of a patient's heart after the native valve is removed.
- This configuration of a suture cuff assembly enables rapid fabrication of a heart valve with minimal contact with the valve body. In addition, this configuration eliminates the need for sutures or pins to secure the sewing cuff to the valve body.
- FIG. 3 Another embodiment of the heart valve of the present invention is depicted partial cross sectional view in FIG. 3 .
- the heart valve comprises a single lock ring 24 secured in groove 22 . More particular, the lock ring 24 is placed in a channel 28 of a stiffening ring 26 , which in turn is disposed within groove 22 of valve periphery 20 .
- One end of outer covering 30 is wrapped around the lock ring 24 and stitched together by representative suture 38 to secure the outer covering to the lock ring 24 .
- the outer material 30 is then folded back on itself and stitched together at opposing ends 40 , 42 by stitching, such as by representative suture 44 .
- the material is preferably folded back and stitched together at a location adjacent the lock ring 24 .
- This configuration of the suture material provides a sufficient amount and thickness of suture material 30 to enable the suture material to be reliably secured in a heart and to fill any space between the valve body and a heart annulus in which the valve is positioned.
- the material is folded back on itself to provide a sewing cuff which is four layers thick. While the embodiment shown has the material folded on itself to provide four layers of material adequate for attachment, more or few layers could be used as well.
- filler material such as filler material 36 depicted in FIG. 2 could also be used in single lock ring embodiments if desired.
- the stiffening ring into which the lock ring is secured on assembly can have a lower vertical height than the two lock ring embodiment.
- the vertical height is a consideration in the application or position the valve is to be inserted. For example, in the aortic position, surgeons prefer to use a smaller valve. Therefore, a valve having a reduced or minimized height may be provided by a single lock ring embodiment.
- the shape, configuration and materials used for the lock ring 24 , the stiffening ring 26 and the outer covering 30 are the same or similar to those described above in reference to the two lock ring embodiment.
- each of the embodiments described above provide for rotation of the valve body 12 within the sewing cuff assembly 18 for ease of positioning following placement within a heart.
- the valve is positioned by the surgeon without the benefit of line of sight access. After placement, the surgeon can manipulate the rotational position of the valve to ensure proper positioning and subsequent operation of the replacement valve.
- the frictional force between the sewing cuff and the valve body is sufficient to prevent rotation therebetween unless manipulated by the surgeon so that the position of the valve is maintained after proper positioning.
- FIG. 4 is a perspective view of a prosthetic heart valve 10 attached to the natural heart tissue, e.g., annulus 50 , of a patient.
- the heart valve is sewn into place by suturing the annulus tissue to the sewing cuff 18 by stitches 52 .
- the lock ring(s) secure the suture material to the valve body 12 and the assembly provides attachment of the prosthetic heart valve in a patient's heart.
Abstract
Description
Claims (23)
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/745,233 US6716244B2 (en) | 2000-12-20 | 2000-12-20 | Sewing cuff assembly for heart valves |
EP01985131A EP1345557A2 (en) | 2000-12-20 | 2001-12-19 | Sewing cuff assembly for heart valves |
CA002443607A CA2443607A1 (en) | 2000-12-20 | 2001-12-19 | Sewing cuff assembly for heart valves |
JP2002550892A JP2004520879A (en) | 2000-12-20 | 2001-12-19 | Sewn cuff assembly for heart valve |
PCT/US2001/050209 WO2002049546A2 (en) | 2000-12-20 | 2001-12-19 | Sewing cuff assembly for heart valves |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/745,233 US6716244B2 (en) | 2000-12-20 | 2000-12-20 | Sewing cuff assembly for heart valves |
Publications (2)
Publication Number | Publication Date |
---|---|
US20020183834A1 US20020183834A1 (en) | 2002-12-05 |
US6716244B2 true US6716244B2 (en) | 2004-04-06 |
Family
ID=24995815
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/745,233 Expired - Fee Related US6716244B2 (en) | 2000-12-20 | 2000-12-20 | Sewing cuff assembly for heart valves |
Country Status (5)
Country | Link |
---|---|
US (1) | US6716244B2 (en) |
EP (1) | EP1345557A2 (en) |
JP (1) | JP2004520879A (en) |
CA (1) | CA2443607A1 (en) |
WO (1) | WO2002049546A2 (en) |
Cited By (157)
Publication number | Priority date | Publication date | Assignee | Title |
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US20030167089A1 (en) * | 2001-12-27 | 2003-09-04 | Ernest Lane | Bioprosthetic heart valve |
US20040059411A1 (en) * | 2000-10-26 | 2004-03-25 | Strecker Ernst Peter | Implantable valve system |
US20040082989A1 (en) * | 2002-08-20 | 2004-04-29 | Cook Incorporated | Stent graft with improved proximal end |
US20040230297A1 (en) * | 2002-04-03 | 2004-11-18 | Boston Scientific Corporation | Artificial valve |
US20050137676A1 (en) * | 2003-12-19 | 2005-06-23 | Scimed Life Systems, Inc. | Venous valve apparatus, system, and method |
US6945957B2 (en) | 2002-12-30 | 2005-09-20 | Scimed Life Systems, Inc. | Valve treatment catheter and methods |
US20060047338A1 (en) * | 2004-09-02 | 2006-03-02 | Scimed Life Systems, Inc. | Cardiac valve, system, and method |
US7007698B2 (en) | 2002-04-03 | 2006-03-07 | Boston Scientific Corporation | Body lumen closure |
US20060095125A1 (en) * | 2004-11-02 | 2006-05-04 | Chinn Joseph A | Attachment of a sewing cuff to a heart valve |
US20060195186A1 (en) * | 2005-02-28 | 2006-08-31 | Drews Michael J | Connectors for two piece heart valves and methods for implanting such heart valves |
US20060195185A1 (en) * | 2005-02-28 | 2006-08-31 | Ernest Lane | Two piece heart valves including multiple lobe valves and methods for implanting them |
US20060235508A1 (en) * | 2005-04-08 | 2006-10-19 | Ernest Lane | Two-Piece Prosthetic Valves with Snap-In Connection and Methods for Use |
US7238200B2 (en) | 2005-06-03 | 2007-07-03 | Arbor Surgical Technologies, Inc. | Apparatus and methods for making leaflets and valve prostheses including such leaflets |
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CA2443607A1 (en) | 2002-06-27 |
EP1345557A2 (en) | 2003-09-24 |
WO2002049546A2 (en) | 2002-06-27 |
JP2004520879A (en) | 2004-07-15 |
US20020183834A1 (en) | 2002-12-05 |
WO2002049546A3 (en) | 2003-02-06 |
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